WO2013156494A1

WO2013156494A1 - Method for the viral inactivation of a biological fluid, and device and container for implementing such a method

Info

Publication number: WO2013156494A1
Application number: PCT/EP2013/057940
Authority: WO
Inventors: Valérie SOULIE
Original assignee: Soulie Valerie
Priority date: 2012-04-19
Filing date: 2013-04-16
Publication date: 2013-10-24
Also published as: CH706420A1

Abstract

The invention relates to a method for the viral inactivation of a biological fluid, comprising: a) a step of treating the biological fluid with a solvent/detergent mixture, b) a step of extracting the solvent/detergent mixture, and c) optionally a step of treating the biological fluid obtained in step b) with a bacteria filter, the extraction step b) being performed only by centrifuging. The invention also relates to a device and a container for implementing said method.

Description

METHOD FOR VIRAL INACTIVATION OF A BIOLOGICAL FLUID, DEVICE AND

CONTAINER FOR THE IMPLEMENTATION OF SUCH A METHOD Technical field

The present invention relates to a viral inactivation method of a biological fluid, comprising a biological fluid treatment step with a solvent / detergent mixture, a device and a container for the implementation of such a device. process.

It relates, more particularly to a method of viral inactivation of a biological fluid, comprising:

a) a step of treating the biological fluid with a solvent / detergent mixture,

b) a step of extracting the solvent / detergent mixture,

c) optionally a step of treating the biological fluid from step b) with a bacterial filter.

State of the art

The viral inactivation of a biological fluid, such as plasma, using the technique of Solvent Detergent (S / D), is a technique used for over 25 years in the industrial field with Triton X detergent - 100® and very large quantities of plasma (giant pool).

The inactivated plasma using the S / D technique, has never transmitted enveloped viruses such as HIV, Hepatitis B and C.

However, once the plasma inactivated, the S / D must be eliminated. Various methods have been developed for extracting S / D, and in particular the use of column chromatography. However, this method is reserved for industrial treatment. Indeed, column chromatography is a method for effective separation but for large volumes, greater than 1500 I. The chromatographic treatment is sometimes preceded by an ultracentrifugation step. This step is a pretreatment that is not necessarily necessary. The centrifugal force used is very high, greater than 1000g. This technique may be too violent for plasma cells. In addition, it requires placing everything first the plasma in tubes for centrifugation before transferring the plasma into columns for chromatography.

Solutions have been sought to treat the plasma in smaller quantities (mini pool). A solution is described in particular in the application WO 2009/1 18331. This application describes a method of viral inactivation of a biological fluid, comprising a step of treating the biological fluid with a solvent / detergent mixture, wherein the step of Extraction of the S / D mixture is carried out by means of soybean oil, the separation of the plasma from the S / D mixture being by decantation under the sole effect of gravity. The process requires the use of numerous pockets in which the plasma circulates to be processed. The use of these many pockets to hang on a gallows makes many manipulations, and increases the duration of treatment. The treatment process is generally carried out between 3h to 8h. In addition, the pockets are made of PVC which tends to diffuse harmful chemical molecules in the plasma. In addition, the control of phase separation is visual, hence many risks of manipulation. Finally, despite the passage of the treated fluid in an activated carbon filter, the treated plasma still contains S / D.

[0007] EP 0 332 786 also discloses an inactivation process comprising the addition of an alcohol to facilitate the removal of the S / D. Phase separation is by sedimentation, with centrifugation being used as an additional method to facilitate separation. However, the influence of alcohol on the plasma is not known, the alcohol potentially having a negative effect on plasma quality.

Also known devices for centrifugation, such as those described in applications WO 97/40942, WO 2009/090991 or US 4190530. These devices use tubes that are placed in a nacelle articulated so as to lift and tilt the tubes during centrifugation. The use of tubes is not easy to easily and quickly treat a large amount of plasma. Accordingly, an object of the present invention is to provide a method of viral inactivation of a biological fluid for rapid treatment, for example less than 30 minutes.

Another object of the present invention is to provide a method of viral inactivation of a biological fluid for automated processing, without risk of human manipulation error.

Another object of the present invention is to provide a method of viral inactivation of a biological fluid for collecting a biological fluid without trace S / D, and without using PVC collection bags.

Another object of the present invention is to provide an automated device for safely treating a biological fluid.

Disclosure of the invention

For this purpose, and in accordance with the present invention, there is provided a method of viral inactivation of a biological fluid, especially blood plasma, comprising:

a) a step of treating the biological fluid with a solvent / detergent mixture,

b) a step of extracting the solvent / detergent mixture, c) optionally a step of treating the biological fluid from step b) with a bacteria filter,

the extraction step b) being carried out essentially by centrifugation, without column chromatography or addition of an extractor product, such as an alcohol or a sorbent.

Advantageously, the extraction step b) is carried out solely by centrifugation.

The present invention also relates to a device for implementing the method as defined above, comprising at least one support for receiving at least one container containing the biological fluid to be treated, means for dispensing a solvent. and a detergent, means for distributing the biological fluid to be treated in said container, optionally at least one bacterial filter, and means for collecting the treated biological fluid, means for agitating the mixture solvent / detergent / biological fluid, and means arranged to allow centrifugation of said solvent / detergent / biological fluid mixture, the container and its support being arranged so that the container has a disk-like shape when said container is positioned on its support.

The present invention also relates to a container for use in the device as defined above, and comprising a reservoir arranged to present the shape of a disc when it is positioned on its support, said reservoir being intended to receive the biological fluid to be treated, the solvent and the detergent, the filling orifices for the biological fluid to be treated, the solvent and the detergent, at least one treated biological fluid recovery conduit arranged to collect the biological fluid from the centrifugation, at least one outlet communicating with said recovery conduit, a coupling comprising a fixed part in which are provided said filling orifices for the biological fluid to be treated, the solvent and the detergent and said outlet orifice, the reservoir being rotatably mounted relative to the fixed portion of said rotating connector.

Such a device and such a container make it possible to implement the method according to the invention by means of a very short duration and to automate the different phases of the treatment.

Brief description of the drawings

The invention will be better understood on reading the following description of embodiments given by way of example and with reference to the drawings in which:

FIG. 1 is a perspective view of a device according to the invention,

FIG. 2 is a perspective view of a first embodiment of the containers according to the invention,

FIGS. 3 and 4 show respectively a perspective view and a sectional view of a second embodiment of the containers according to the invention,

FIG. 5 is a perspective view of a support used with the container of FIGS. 3 and 4, and - Figures 6 and 7 show respectively a perspective view and a sectional view of another embodiment of the containers according to the invention.

Mode (s) of realization of the invention

The present invention relates to a method of viral inactivation of a biological fluid, such as blood plasma, comprising:

a) a step of treating the biological fluid with a solvent / detergent mixture,

the extraction step b) being carried out essentially by centrifugation, without column chromatography or addition of an extractor product, such as an alcohol or a sorbent. In the present invention, "essentially" means that centrifugation is the main technique used, if not the only one, for removing at least 95% of the S / D mixture, and preferably at least 98% of the S / D mixture.

In a preferred manner, the extraction step b) is carried out by centrifugation only.

Advantageously, the duration of the centrifugation can be less than 20 minutes, preferably less than 15 minutes, and more preferably less than 10 minutes.

Advantageously, the centrifugation speed may be less than 6000 rpm, preferably less than 5000 rpm, and more preferably less than 4500 rpm.

Preferably, the centrifugal force is less than 2000g and preferably between 1000g and 2000g.

Advantageously, steps a) and b) can be performed in the same container, step a) corresponding to stirring and step b) said centrifugation. Advantageously, the duration of the stirring is less than 20 minutes, preferably less than 15 minutes, and more preferably less than 10 minutes.

Preferably, the stirring is a rotation stirring.

Advantageously, the method according to the invention further comprises a step d) of collecting the biological fluid from step c) in collection pockets.

Advantageously, the total duration for the implementation of steps a) to c) is less than 40 minutes, preferably less than 30 minutes, and generally between 20 and 40 minutes.

The present invention also relates to a device for implementing the method as defined above, comprising at least one support for receiving at least one container containing the biological fluid to be treated, means for dispensing a solvent and a detergent, means for distributing the biological fluid to be treated in said container, optionally at least one bacterial filter, and means for collecting the treated biological fluid, means for agitating the solvent / detergent / biological fluid mixture, and means arranged to allow centrifugation of said solvent / detergent / biological fluid mixture. The container and its support are arranged so that the container has a disk-like shape when said container is positioned on its support.

According to an alternative embodiment, the container may comprise a body made of a rigid material and having the shape of a thick disc whose diameter is greater than the thickness. According to another embodiment, the container is made of a soft material chosen to take the form of a disc when it is positioned on the support.

Advantageously, each container may be provided both of said means for agitating the solvent / detergent / biological fluid mixture and said means arranged to allow centrifugation of said solvent / detergent / biological fluid mixture. Preferably, the means for agitating the solvent / detergent / biological fluid mixture are means arranged to cause a rotation stirring of said container.

Preferably, the means arranged to allow centrifugation of said solvent / detergent / biological fluid mixture are means arranged to rotate said container perpendicularly to the axis of said container. Thus, the container remains horizontal during the centrifugation.

Advantageously, the solvent and detergent dispensing means and the distribution means of the biological fluid to be treated are arranged to dispense the solvent, the detergent and the biological fluid to be treated in the same reservoir.

Advantageously, the collection means comprise at least one pump arranged to collect, in the reservoir, the biological fluid treated after centrifugation. The collection means may also comprise at least one collection bag intended to contain the treated biological fluid.

Preferably, the device according to the invention further comprises at least one mixing tank for containing a solvent / detergent mixture, said mixing tank being connected to the solvent and detergent dispensing means.

Advantageously, the device according to the invention further comprises at least one phase detector, arranged to stop the movement of the biological fluid treated in the collection means during detection of a foreign component in said biological fluid.

Preferably, the device according to the invention comprises a motor per container support.

Advantageously, the device according to the invention further comprises a control unit arranged to calculate the volume of solvent and detergent depending on the volume of biological fluid to be treated. The control unit can be further arranged to manage the data relating to an operator, the steps, the solvent, the detergent, the biological fluid to be treated, treated biological fluid. The control unit may further be arranged to control the process parameters.

More specifically, the control unit provides the user with an ergonomic control panel for controlling the devices. It follows sequentially the different stages of the process, automates the treatments and guides the user:

• the user turns on the containers he wants to use and asks the control unit to prepare a new treatment by selecting these containers.

• the control unit verifies that the containers are operational and orders their heating.

• The control unit prompts the user to enter the information about the execution, either manually or with the barcode reader.

• the user installs the fluids to be treated, the containers and checks the level of the reagents.

• the user requests the start of the treatment.

• The control unit verifies the consistency of the data entered by the user, verifies that the device has been correctly prepared and sequentially triggers the different processing steps on each container in parallel.

• Throughout the process, the control unit takes care of repatriating the information provided by each container and displays them in an intelligible manner for the user. If an inconsistency is detected, the control unit orders the process to stop.

• the user can stop the process at any time via the control unit, or directly on the device.

• at the end of processing, the information related to the execution of the process is saved. Each collection pocket is assigned an identification number associated with a printable bar code on a self-adhesive label. • the user unloads used equipment and collection pockets. A new treatment can be started.

The present invention also relates to a container intended to be used in the device as defined above, and comprising a reservoir arranged to present the shape of a disc when it is positioned on its support, said reservoir being intended to receive the biological fluid to be treated, the solvent and the detergent, the filling orifices for the biological fluid to be treated, the solvent and the detergent, at least one treated biological fluid recovery conduit arranged to collect the biological fluid from the centrifugation, at least one outlet communicating with said recovery conduit, a coupling comprising a fixed part in which are provided said filling orifices for the biological fluid to be treated, the solvent and the detergent and said outlet orifice, the reservoir being rotatably mounted relative to the fixed portion of said rotating connector.

Advantageously, the fixed part of the rotary coupling comprises a peripheral cylindrical groove communicating on the one hand with said recovery conduit and on the other hand with said outlet orifice.

Preferably, the tank may have on its bottom grooves arranged to improve the fluidic movements.

Advantageously, the reservoir has a shape arranged on the one hand to improve the mixing of the biological fluid with the solvent and the detergent, and on the other hand to better distinguish a phase constituted by the treated biological fluid, a phase constituted by the solvent / detergent mixture and optionally a phase consisting of the fatty part of the biological fluid. In addition, the disc shape of the tank allows to have no blind spots where viruses could lodge and thus escape treatment.

Preferably, the reservoir has the shape of a disk. A cylindro-conical shape can also be envisaged.

In addition, the reservoir may be arranged to have an inner peripheral groove. When the reservoir is made of a rigid material, the groove is provided on the inner side wall of the container. When the reservoir is made of a soft material, the groove is provided on the outer side wall of the support, so that the container matches the shape of its support and also has the groove. This groove is preferably positioned at a different level of the recovery conduit. During centrifugation, the detergent concentrates in the groove and remains stuck to the container wall, allowing the plasma to be recovered only.

Advantageously, the container according to the invention may further comprise positioning means arranged to position and fix it on its support.

The method according to the invention allows the treatment of a biological fluid, such as blood plasma or cryoprecipitate to remove viruses, bacteria, pyrogens, etc. The plasma can come from a donor single or compatible donors, and may be at room temperature. The treated plasma is then used for transfusion.

This method is implemented by means of a device for automating the different phases of the treatment.

This automated device comprises a system of disposable filter-tubes-reservoirs containing the plasma or cryoprecipitate to be treated and in which the entire treatment will take place. This system is disposable after each use.

The whole is controlled by a PC with software for:

• control the automaton,

• follow and trace the progress of operations,

• check the status of the PLC (especially the volumes of reagents at start-up and execution, compliant loading of tanks and connectors) etc.

• manage operator-related data (inputs, outputs, storage), processed samples, and executed operations

• generation of a barcode system to identify the final product and print identification labels.

Several devices according to the invention can be connected to the same computer and controlled by the same software. According to a preferred embodiment, the automaton device makes it possible to treat

4 containers of up to 300 ml per cycle, containing 250 ml of fluid. It is obvious that the number of containers to be treated may vary, depending on the size of the PLC device.

The device according to the invention has a small footprint and can be arranged in a parallelepipedic tank of about 60x60x20 cm.

The 4 containers have individual engines. The container according to the invention is made of polypropylene and / or polycarbonate. The materials chosen are chemically inert and sterilizable. The viral inactivation container according to the invention is disposable, to treat volumes of less than 2000 ml of plasma and preferably 400 ml to 1000 ml of plasma.

The device also includes a bacterium filter of 0.2 u, and 2 to 5 collection transfusion bags to recover the fluid after treatment.

All its elements are interconnected and sterilized either with ΙΈΤΟ (ethylene oxide) or with gamma rays (method validated in accordance with the standards

UNI EN ISO 11 137-1-2-3). All these elements are chosen to contain no phthalates.

The pipes are for example polyvinyl chloride (PVC) without phthalates or C-Flex®.

Spike-type perforating devices comprising an ABS body and equipped or not with an automatic filter (0.2 μΙ) are also used. This device prevents microorganisms from entering the system.

In addition, each device comprises means for controlling the temperature. The S / D reagents and the fluid (Plasma or Cryoprecipitate) to be treated must be maintained at 28 ° C (+/- 3 ° C) throughout the process until the phase separation step.

The detergent is a corrosive fluid. Solvent and detergent contained in separate bottles are loaded separately into the controller. Their mixing is done in a separate tank provided on the automaton before adding the mixture to the container.

Detergent D is preferably Triton X-45 ®, used at 1% of the volume of the biological fluid to be treated. The solvent S is preferably TnBP (tri-n-butyl phosphate), used at 1% of the volume of the biological fluid to be treated. It is obvious that any other detergent and solvent known to those skilled in the art for this application can be used. Solvent and detergent are supplied in separate flasks.

The S / D mixture is preferably equal parts, the mixture being stable for 1 day at 28 +/- 3 ° C. Depending on the volume of the biological fluid to be treated, 2% of the S / D mixture is preferably added.

According to the process of the invention, the S / D mixture is prepared every morning for 5 to 10 uses of 5 to 10 devices. Simply place the connectors supplied on the S and D bottles supplied, place the tubes in pinch valves and connect them to the mixing tank.

S / D. Every day connectivity will be discarded at the end of the day and replaced the next day.

The device according to the invention comprises an agitator arranged to mix equal parts of the S / D through the control of soft pumps used to collect the solvent and detergent. The S / D is mixed in the mixing tank which is constantly stirred and heated to 28 +/- 3 ° C.

Disposable containers are identified by bar code and are placed in the PLC device, respecting the locations of the containers and connectors. The containers are arranged on supports arranged to be movable at least in rotation, to ensure both agitation and centrifugation.

Then the biological fluid that is already at room temperature is connected to the device of the invention through sterile connections, without the need to work under sterile conditions.

Then, the biological fluid is distributed in the containers according to the invention through pumps. The distribution is calculated by the device of the invention.

The biological fluid is heated at 28 +/- 3 ° C for 10 min for example.

The S / D mixture is distributed in the center of the container, through the openings provided in the rotating connection, at a rate of 2% of the volume of the biological fluid contained in the containers. The distribution of S / D is preferably less than 20 minutes and more preferably less than 15 minutes while simultaneously the containers are stirred by rotating rotation.

The oscillation frequencies are preferably between 50 to 150 oscillation / min (1 oscillation = 1 go / return). The angular rotation speed is preferably between 4.1 1 rad / s and 16.45 rad / s. According to the embodiments, the amplitude is 90 ° (+/- 45 °) to 120 ° (+/- 60 °). The duration of the stirring is preferably less than 10 minutes.

The tubes do not intermingle thanks to the tight rotating connections present on the containers. Then the containers are automatically set in motion to create transfers or displacements of materials by centrifugation. Centrifugation is carried out by rotating the containers. The rotation speed is preferably less than 4500 rpm, the centrifugal force is preferably between 1000 to 2000g and the duration of the centrifugation is preferably less than 10 minutes.

The separation of the constituents is achieved by combining viscous effects and submitting to radial force fields. The biological fluid is then separated from the S / D and all fats. Collection of the treated biological fluid (without S / D) can be performed when the reaction tanks are moving and / or during the entire deceleration phase.

The biological fluid separated from the solvent and the detergent is collected using a peristaltic pump. Two orifices located at the ends of the tanks communicating with two cannulas opening into the rotating connection allow the passage of the biological fluid treated in said rotating connection without said fluid being mixed with the solvent, detergent and fat of the biological fluid.

The phase detectors make it possible to stop the movement of the fluids during a component detection other than the biological fluid to be treated. The peristaltic pump is immediately stopped. A selector valve allows the fluidic circuit to change lines (air filter position 0,2μ). At this time the pump is activated allowing the suction of the biological fluid treated in the new pipe.

The treated biological fluid is then directed to the bacteria filter. The bacteria filter placed vertically or horizontally is impregnated with the biological fluid initially through sterile airvents, then all the biological fluid is filtered vertically or horizontally.

The biological fluid is then distributed into the collection transfusion bags. Pocket distribution will depend on the initial plasma theft. The pockets will have a minimum of 200ml.

The automatic device ensures a perfect mixture of S / D and biological fluid and a perfect separation of the biological fluid from all other constituents (S + D + fat).

In case of problems (not enough reagents, temperature problem, poorly placed pipes), the controller device comprises security means for stopping the process.

It can be provided that the device according to the invention comprises means arranged to cut the collection pockets at the end of the treatment. Otherwise this operation can be done manually.

The pockets of treated biological fluid are recovered, and they are used according to the habits of the transfusion center (freezing or transfusion).

In addition to the viral inactivation of enveloped viruses such as HIV, Hepatitis B and C, the method according to the invention allows the conservation of the most important proteins and the elimination of bacteria. The biological fluid thus treated will be transfused mainly to patients with hemophilia, heart transplants, severe traumas, and patients with liver disease.

Figure 1 shows an embodiment of a device according to the invention. The device comprises a tank 1 having four housings enclosing four receptacles 2. Each receptacle 2 has a rotating connection 4 and a reservoir 6. The rotating connection 4 comprises an inner part 8 fixed with respect to the reservoir 6 and comprising the inlet for the fluid to be treated, the inlet for the S / D mixture and the outlet for the treated fluid. Each container 2 is mounted for example by clipping on its respective motor or rotor 10.

The device also comprises the mixing tank S / D 12 fed by the solvent contained in the tank 14 and the detergent contained in the tank 15. Various peristaltic pumps 16 and connecting tubes

(not shown) are used to move different liquids from one point to another. A dispensing valve 18 is provided for dispensing the biological fluid and the S / D mixture to the different containers. A collection valve 20 is placed above the dispensing valve 18 and ensures the collection of the treated biological fluid. Each output tube of the collection valve is positioned on an infrared optical sensor 22. These sensors will detect a phase change between the treated fluid and the S / D mixture. The peristaltic pump then directly stopped, thus avoiding contamination of the plasma or cryoprecipitate treated. Additional security can be envisaged, by placing a pinch valve 24 at each tube to stop the movement of the fluid.

A first selection valve 26 is provided to bring the treated fluid from each container to the bacteria filter 28. A second selection valve 30 is required for filling the collection pockets.

Referring to Figure 2, there is shown a first alternative form of containers according to the invention, this form being cylindro-conical. Each container 2 is disposed on the mobile support 32. The rotating connection (not shown) for managing the liquid inlets and outlets is arranged in the center of the support 32.

Referring to Figures 3 and 4, there is shown a second alternative form of containers according to the invention, this form being a disk.

Each container 2 is composed of a reservoir 40 for containing the fluid mixture to be treated and S / D. It is provided with a centering pin 41 and positioning on its rotor 10. The upper part makes it possible to position the rotating coupling 4. The container is provided with lugs 42 for fixing in the rotor 10. The positioning will be done on 1/8 turn. An attachment system with spring return will hold the container in position during the entire handling phase.

The disk form has many advantages:

- optimization of the efficiency of the separation and reduction of the necessary time.

reduction of the height of the device.

- simplification of the design and construction of the rotating connection (reduction of production cost).

no balancing is necessary, its axis being perpendicular to the axis of rotation.

The rotating connector 4 is held on its support by means of a ring 44. Two lateral conduits 46 communicating with the reservoir at the periphery of the disc make it possible to recover the treated fluid resulting from the centrifugation and concentrating at said periphery of the disc.

Another conduit 48 housed in the movable part of the rotary coupling 4 allows the passage of the fluid to the fixed part 4a of the rotating connector 4. The fluid outlet is through the port A, via A cylindrical groove 50. The reservoir is filled by the orifice B. Once the reservoir is filled, the operator will fix a non-return valve provided with a filter.

The seal is provided by two rotary joints 52 provided on each side of the cylindrical groove 50.

Another rotary joint 54 provides a rotation without friction between the fixed and rotating parts of the rotary coupling 4.

FIG. 5 shows the rotor 10 associated with the container of FIGS. 3 and 4. The rotor 10 is provided with a bore 56 for centering and positioning the container 2 in the form of a disc. This central hole allows its attachment to the motor shaft by means of a coupling device 58.

The rotor 10 is equipped with 6 notched grooves 60 for the positioning of the disk-shaped container 2 with a spring return fastening system for holding in position during the entire handling phase. Referring to Figures 6 and 7, there is shown another alternative container according to the invention, wherein a peripheral groove 70 is provided on the inner side wall of the container 72.

The device according to the invention allows not to use oil to extract the S / D mixture and therefore also to remove the activated carbon filter. The process according to the invention makes it possible to obtain an inactivated biological fluid without trace of solvent or detergent. The device according to the invention makes it possible to automate the treatment method, any source of human error then being suppressed. In addition, the agitation and centrifugation are performed in the same container, which reduces the number of containers to use and transfer the fluid from one to the other. The method according to the invention also makes it possible to reduce the duration of treatment to inactivate the biological fluid.

Claims

claims

A method of viral inactivation of a biological fluid, comprising:

a) a step of treating the biological fluid with a solvent / detergent mixture,

b) a step of extracting the solvent / detergent mixture,

c) optionally a step of treating the biological fluid resulting from step b) by a bacterial filter,

characterized in that the extraction step b) is carried out essentially by centrifugation and without column chromatography.

2. Method according to claim 1, characterized in that the extraction step b) is carried out solely by centrifugation.

3. Method according to any one of the preceding claims, characterized in that the duration of the centrifugation is less than 20 minutes, preferably less than 15 minutes, and more preferably less than 10 minutes.

4. Method according to any one of the preceding claims, characterized in that the centrifugation speed is less than 6000 rpm, preferably less than 5000 rpm, and more preferably less than 4500 rpm.

5. Method according to any one of the preceding claims, characterized in that the centrifugal force is less than 2000g, and preferably between 1000g and 2000g.

6. Method according to any one of the preceding claims, characterized in that steps a) and b) are performed in the same container (2), step a) corresponding to stirring and step b) to said centrifugation.

7. Method according to claim 6, characterized in that the duration of the stirring is less than 20 minutes, preferably less than 15 minutes, and more preferably less than 10 minutes.

8. Method according to any one of claims 6 and 7, characterized in that the stirring is a rotation stirring.

9. Method according to any one of the preceding claims, characterized in that it further comprises a step d) of collecting the biological fluid from step c) in collection pockets.

10. Method according to any one of the preceding claims, characterized in that the total duration for the implementation of steps a) to c) is less than 40 minutes, and more preferably less than 30 minutes.

1 1. Device (1) for implementing the process defined by any one of claims 1 to 10, comprising at least one support (10) for receiving at least one container (2) containing the biological fluid to be treated, means for dispensing a solvent and a detergent, means for distributing the biological fluid to be treated in said container (2), optionally at least one bacterial filter (28), means for collecting the treated biological fluid, means for agitating the solvent / detergent / biological fluid mixture, and means arranged to allow centrifugation of said solvent / detergent / biological fluid mixture, characterized in that the container (2) and its support (10) are arranged so that the container (2) has a disc shape when said container (2) is positioned on its support (10).

12. Device according to claim 1 1, characterized in that each container (2) is provided both of said means for agitating the solvent / detergent / biological fluid mixture and said means arranged to allow centrifugation of said solvent / detergent / fluid mixture organic.

13. Device according to any one of claims 1 1 and 12, characterized in that the means for agitating the solvent / detergent / biological fluid mixture are means arranged to cause rotational agitation of said container.

14. Device according to any one of claims 1 1 to 13, characterized in that the means arranged to allow centrifugation of said solvent / detergent / biological fluid mixture are means arranged to rotate said container perpendicular to the axis of said container.

15. Device according to any one of claims 1 1 to 14, characterized in that the solvent and detergent dispensing means and the distribution means of the biological fluid to be treated are arranged to dispense the solvent, the detergent and the fluid biological to be treated in the same tank (2).

16. Device according to any one of claims 1 1 to 15, characterized in that the collection means comprise at least one pump arranged to collect, in the reservoir, the biological fluid treated after centrifugation.

17. Device according to any one of claims 1 1 to 16, characterized in that the collection means comprise at least one collection bag for containing the treated biological fluid.

18. Device according to any one of claims 1 1 to 17, characterized in that it further comprises at least one mixing tank (12) for containing a solvent / detergent mixture, said mixing tank (12) being connected the solvent and detergent dispensing means.

19. Device according to any one of claims 1 1 to 18, characterized in that it further comprises at least one phase detector (22), arranged to stop the movement of the biological fluid treated in the collection means when the detection of a foreign component in said biological fluid.

20. Device according to any one of claims 1 1 to 19, characterized in that it comprises a motor by container support.

21. Device according to any one of claims 1 1 to 20, characterized in that it further comprises a control unit arranged to calculate the volume of solvent and detergent depending on the volume of biological fluid to be treated.

22. Device according to claim 21, characterized in that the control unit is further arranged to manage the data relating to an operator, the steps, the solvent, the detergent, the biological fluid to be treated, the biological fluid treated.

23. Device according to claim 22, characterized in that the control unit is further arranged to control the process parameters.

24. Container (2) for use in the device defined in any one of claims 1 1 to 23, characterized in that it comprises a reservoir (40) arranged to have the shape of a disc when is positioned on its support, said reservoir (40) being intended to receive the biological fluid to be treated, the solvent and the detergent, the filling orifices (B) for the biological fluid to be treated, the solvent and the detergent, at least one recovery duct (46) of the treated biological fluid arranged to collect the biological fluid resulting from the centrifugation, at least one outlet orifice (A) communicating with said recovery duct (46), a rotating connection (4) comprising a fixed part (4a) in which are provided said filling orifices (B) for the biological fluid to be treated, the solvent and the detergent and said outlet port (A), the tank (40) being rotatably mounted relative to the stationary portion (4a) of the rotatable coupling (4).

Container according to claim 24, characterized in that the fixed part (4a) of the rotary coupling (4) comprises a peripheral cylindrical groove (50) communicating on the one hand with said recovery conduit (46) and on the other hand with said outlet port (A).

26. Container according to any one of claims 24 and 25, characterized in that the reservoir (40) has on its bottom grooves arranged to improve the fluid movements.

27. Container according to any one of claims 24 to 26, characterized in that the reservoir is arranged to have an inner peripheral groove.

28. Container according to any one of claims 24 to 27, characterized in that it further comprises positioning means arranged to position and fix it on its support.